Defendants Rack Up Another State Court Win in Mensing and RLD Liability Theory Decisions

Following the recent decision by the U.S. Court of Appeals for the First Circuit in Bartlett v. Mutual Pharmaceutical Co., which our friends over at the Drug and Device Law Blog commented on as making no sense (“while a simple warning claim involving a generic drug is indisputably preempted under PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), a claim much more fundamentally in conflict with FDA approval of generic drugs – that state tort law can impose liability for not removing an FDA-approved product off the market entirely – supposedly is not”), we’re happy to report on another decision – a state court decision – that turned out the other way and that provides yet another rebuke of the so-called Reference Listed Drug (“RLD”) theory of liability.

As we’ve previously discussed (here, here, and here), the RLD theory of liability goes something like this: because FDA’s regulations impose new or additional responsibilities on an ANDA sponsor whose drug product is unilaterally designated by FDA as an RLD in the Orange Book when the brand-name NDA RLD is no longer marketed, the U.S. Supreme Court’s pro-preemption Mensingdecision is inapplicable and a court should instead employ the preemption analysis utilized in the Court’s decision in Wyeth v. Levine, 555 U.S. 555 (2009), concerning NDA’d drug products. Every court (federal and state) that has thus far been asked to accept the RLD theory of liability has refused to do so (see here). Invariably, the courts have said that RLD status of an ANDA’d drug product (even in the case of a drug product approved under an ANDA pursuant to an approved suitability petition) does not convert a generic drug manufacturer into a brand-name drug manufacturer with the right to use FDA’s Changes Being Effected (“CBE”) process to change drug labeling.

The most recent rejection of the RLD theory of liability comes out of the Superior Court of New Jersey in In re Reglan Litigation, Case No. 289 (N.J. Super. Ct. May 4, 2011), and involes the familiar drug metoclopramide (in tablet, syrup, and injectable dosage forms). Plaintiffs sued several generic drug manufacturers, including Morton Grove Pharmaceuticals, Inc. (“MGP”) whose ANDA’d metoclopramide syrup drug product is identified in FDA’s Orange Book as an RLD.

Plaintiffs’ Second Master Long Form Complaint pled several causes of action (e.g., defective design, failure to warn, negligence, negligence per se, fraud, misrepresentation and suppression, constructive fraud, breach of express and implied warranties, unfair and deceptive trade practices, and unjust enrichment) that the court (Judge Carol E. Higbee) said in its decision granting Defendants’ Motion to Dismiss are “all based on generic manufacturers’ alleged failure to provide adequate information or warnings, and thus are preempted under Mensing.” Only to the extent that any generic drug manufacturer failed to update its drug product labeling to be the same as the brand-name label would such manufacturer be excluded from preemption, as such “absense of ‘sameness’ runs afoul of the preemption ruling in Mensing.”

Plaintiffs attempted to argue around Mensing with various theories, including that the FDA Amendments Act of 2007 (“FDAAA”) altered the preemption analysis, that federal law permits generic drug manufacturers to disseminate “Dear Doctor Letters” or otherwise communicate warnings to the medical community thereby making compliance with both state and federal laws possible, and that the generic drug manufacturers could have simultaneously complied with federal and state law duties by suspending product sales. Judge Higbee rejected each theory, stating, for example, that:

While it is true that the Supreme Court in Mensing considered federal statutes and regulations that were in place before [FDAAA] took effect, it is clear that the amendments do not change or eliminate any ofthose laws or regulations which control this decision. The “sameness” requirement remains in full effect. The generic manufacturers’ inability to use the CBE process to unilaterally change their warnings also continues. . . . The new changes in FDAAA do not eliminate or alter the conflict the Supreme Court described in Mensing. As a result, claims based on any such duty are preempted post-FDAAA to the same extent as they were pre-FDAAA. . . .

Plaintiffs’ “failure to suspend sales” argument is a solution that goes beyond the duties and remedies that have ever been applied in state courts. The duty has always been to prove that the product was defective, not that it should have been withdrawn from the market. Tort law remedies allow compensation but never an order to stop selling the product.

In a separate decision directed to Plaintiffs’ RLD theory of liability arguments against MGP, Judge Higbee said that there is insufficient authority for Plaintiffs’ argument that FDA’s unilateral designation of an ANDA’d drug product as an RLD means that the generic drug manufacturer can strengthen its label independently through the CBE process:

Plaintiffs fail to cite to any case, statute, or regulation that supports the argument that the product labeling can be unilaterally altered without FDA’s prior approval simply because the generic manufacturer has been designated as an RLD. It is very difficult to conclude that the FDA’s unilateral designation is sufficient to automatically transform [MGP], an ANDA holder, into an NDA holder. In fact, the FDA regulations are clear in putting the agency in charge when no NDA holder is in the market. . . . At this point in time, this court refrains from imposing additional obligations over and above what the regulations have indicated. The court concludes that Mensing’s preemptive impact on plaintiffs’ claims against [MGP] is not diminished by the fact that [MGP] has been designated as an RLD, because this designation does not turn it into a brandname manufacturer.